The U.S. FDA has expanded its clearance for P-Cure’s compact proton therapy system, allowing its use for full-body treatments and in the supine position.

This broadens the original authorization, which was limited to seated delivery for cancers of the brain, head and neck, and thorax.

The updated indication, announced by the Shilat, Israel-based company, supports treatment of virtually any anatomical site eligible for proton therapy. It also enables supine treatment for pediatric patients under anesthesia, aligning with common radiotherapy practices.
“With this FDA clearance, we can now enable focused, high-precision treatment to any anatomical site and virtually any type of tumor eligible for radiotherapy—whether it’s the brain vertex or the prostate,” said Dr. Michael Marash, founder and CEO of P-Cure. “This expansion supports the clinical flexibility to treat anesthetized pediatric patients in the widely accepted supine position and choose the optimal treatment posture for each case—seated or supine—based solely on the physician’s judgment.”

The P-Cure system uses synchrotron-based intensity modulated proton therapy (IMPT) for targeted dose delivery while minimizing secondary neutron radiation. It also includes in-room diagnostic CT for image-guided and adaptive therapy, robotic patient support with multiple positioning options, and orthogonal X-ray imaging for motion management.

Unlike traditional gantry-based systems, P-Cure’s gantry-less architecture enables installation in vaults originally designed for linear accelerators, potentially lowering infrastructure costs and expanding access to proton therapy.

“The process required meticulous planning, clinical justification, rigorous testing, and a relentless team effort,” said Ori Lubin, head of quality and regulatory affairs at P-Cure. “This clearance validates the system’s performance across multiple treatment orientations and anatomical targets, with safety and clinical utility at the core.”

The company positions its system as a cost-effective alternative for hospitals and regional centers seeking to expand radiation oncology capabilities.

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